JP2012096051A - System and method for dental appliance compliance indication - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide effective data for communicating apparatus compliance with patients, including increased patient knowledge and recall of appliance usage, increased compliance in wearing the dental appliance, and increased patient satisfaction as a result.SOLUTION: An apparatus for monitoring orthodontic treatment compliance includes: an appliance 15 adapted to be worn over one or more teeth; and a compliance indicator 100 mounted on the appliance 15 to indicate compliance.

Description

The present invention relates to a system and method for compliance indication of dental instruments. Repositioning teeth, as described in commonly-assigned US Pat. No. 5,637,097, the title of the invention “Methods and systems for current tooth repositioning and maintenance delivery” (the contents of which are incorporated herein) The assignee of the present invention is Align Technology, Inc. May be achieved through the use of a series of removable resilient positioning devices, such as the Invisalign® system available from. Such appliances generally have a thin shell of resilient material that fits the patient's teeth but is slightly offset from the initial or previous tooth structure. The placement of a resilient positioner on the tooth applies a controlled force to a specific position and gradually moves the tooth to a new position. By repeating this process using a series of instruments including the new arrangement, the teeth are eventually moved to the final desired arrangement via a series of intermediate arrangements or intermediate alignment patterns. A complete description of an exemplary elastic polymer positioning device is described in US Pat.
The appliance is effective for tooth repositioning when attached to a patient's teeth. Although easy to wear and easy to use, the patient may not wear the appliance as defined by the doctor or orthodontist. If the instrument is removed for any reason beyond the recommended period, it will interfere with the treatment plan and extend the overall treatment period. Because the device is removable by the patient, the doctor must rely on the patient to comply with the prescription.

US Pat. No. 6,607,382 US Pat. No. 5,975,893 International Publication No. 98/58596

The present invention provides, for example:
(Item 1)
A device for monitoring compliance of orthodontic treatment,
An appliance adapted to be worn on one or more teeth;
A compliance indicator attached to the device indicating compliance;
An apparatus comprising:
(Item 2)
The apparatus of item 1, wherein the device is used in conjunction with a predetermined period of treatment.
(Item 3)
The apparatus of item 1, wherein the compliance is indicated by one of a visual, chemical, and physical change of the indicator.
(Item 4)
The apparatus of item 1, wherein the compliance is indicated visually, chemically or physically.
(Item 5)
The apparatus of claim 1, wherein the change is affected by one of moisture, temperature, chemical, and biological factors.
(Item 6)
The apparatus of item 1, wherein the change comprises one of a change in color, shape, and size.
(Item 7)
Item 4. The apparatus according to Item 3, wherein the change can be detected by human vision or machine vision. (Item 8)
Item 2. The device of item 1, wherein the change is affected by degradation of the biodegradable or dissolvable polymer.
(Item 9)
The apparatus of item 1, wherein the compliance is indicated by a decrease in the size of the indicator.
(Item 10)
The apparatus of item 1, wherein the compliance is indicated by the presentation of color in the presence of the polymer.
(Item 11)
Item 11. The apparatus of item 10, wherein the color presentation occurs after decomposition or dissolution.
(Item 12)
The apparatus of item 1, wherein the compliance is indicated by the release of the colorant.
(Item 13)
Item 13. The device of item 12, wherein the colorant is released through a semipermeable membrane.
(Item 14)
The apparatus of item 1, wherein the compliance is indicated by a color change.
(Item 15)
15. A device according to item 14, wherein the color change is caused by a reaction between one or more elements in the indicator due to a chemical reaction of oral fluid.
(Item 16)
Item 15. The device of item 14, wherein the color change is caused by releasing a colorant into the oral fluid.
(Item 17)
The apparatus of item 1, wherein the indicator comprises a colored pressure sensitive adhesive having a backing film.
(Item 18)
Item 18. The device of item 17, wherein the compliance is indicated based on a loss of color of the pressure sensitive adhesive layer.
(Item 19)
The apparatus of item 1, wherein the indicator collects oral fluid.
(Item 20)
Item 20. The device according to item 19, wherein compliance is indicated by a change in concentration of a component in the oral fluid.
(Item 21)
Item 20. The device of item 19, wherein compliance is indicated by a lack of change when the device is worn.
(Item 22)
The apparatus of item 1, wherein the compliance is indicated by a chemical reaction through the semipermeable membrane.
(Item 23)
The apparatus of item 1, wherein the compliance is indicated by mechanical deformation during movement by orthodontics.
(Item 24)
The apparatus of item 1, wherein the compliance is indicated by a change in electrical resistance.
(Item 25)
25. The apparatus of item 24, comprising one or more conductive fillers positioned on the indicator.
(Item 26)
The apparatus of item 1, wherein the compliance is indicated by a change in permeability of the stretched polymer or stretched membrane.
(Item 27)
The apparatus of item 1, wherein the compliance is indicated by mass transfer or chemical reaction.
(Item 28)
The apparatus of item 1, wherein the compliance is indicated by a change in optical properties due to stretching of the polymer network.
(Item 29)
The device of claim 1, wherein the substance provides pain relief.
(Item 30)
The apparatus according to item 1, wherein the indicator comprises a strip of time and temperature for detecting a wearing period in a predetermined temperature range.
(Item 31)
The apparatus of item 1, wherein the indicator comprises a plurality of brushes each having a color core that is gradually presented while being used to indicate compliance.
(Item 32)
The apparatus of claim 1, wherein the indicator comprises a plurality of brushes each having an increased usage indication while being used to indicate compliance.
An apparatus for monitoring compliance of orthodontic treatment includes an appliance adapted to be worn on one or more teeth and a compliance indicator attached to the appliance or tooth indicating compliance.
Advantages of the system include one or more of the following. The device is intended to communicate patient device compliance, including improving patient knowledge and recall about the use of the appliance, improving compliance when wearing dental appliances, and consequently improving patient satisfaction. Provide more effective data. The device provides a self-monitoring channel for the patient. The device also reduces the patient's level of anxiety without the need for verbal or written instructions because the device usage is well understood. The doctor or orthodontist also has more useful information about the patient's progress during treatment.

FIG. 1 shows an exemplary compliance indicator. 2A-2C show a first embodiment of the compliance indicator of FIG. 3A-3B show a second embodiment of the compliance indicator of FIG. 4A-4B show a third embodiment of a compliance indicator. FIG. 5 shows a fourth embodiment of the compliance indicator. FIG. 6 shows a fifth embodiment of the compliance indicator. FIG. 7 shows a sixth embodiment of the compliance indicator. FIG. 8 shows a seventh embodiment of the compliance indicator. FIG. 9 shows an eighth embodiment of the compliance indicator.

(Explanation)
FIG. 1 shows a typical removable instrument 15 adapted to fit the teeth of the jaw 16. The usage indicator 100 can be attached to a tool 15 that indicates a single tooth or patient compliance.

  In one embodiment, indicator 100 may be a coating on a device having teeth or chemical agents. Alternatively, the indicator 100 may be an electrical agent, an optical agent, or a mechanical agent that indicates wear of the device. In one embodiment, the indicating agent is inactive until contact with a liquid or vapor. Alternatively, drug release can be facilitated by liquid or vapor. Thus, in one case, as soon as it is worn, the oral fluid activates the drug, allowing the drug to leach out and exhibit compliance. Alternatively, oral fluid such as saliva, among others, can penetrate to activate drugs that exhibit compliance.

  In another embodiment, when the appliance is worn on a tooth, the appliance can release a colorant into the oral environment. Such means may comprise a layer comprising a drug. The layer may be formed on at least a portion of the surface of the repositioning device. These surfaces include both the cavity surface, which is the surface within the cavity that contacts the teeth at a predetermined location, and the external surface, which is the surface of the appliance that contacts the cheeks and lips at a predetermined location. The layers may be composed of various materials and may take various forms. For example, the layer may consist essentially of a drug. In other words, the drug may be attached directly to the surface of the polymer shell of the resilient repositioning device. This may be accomplished by applying the surface agent (optionally in an inert carrier or diluent) itself using many methods such as spraying, painting, and / or dipping. Once the repositioning device is attached to the patient's teeth, the drug may then be released into the oral environment.

  Alternatively, the layer may include an agent present in or on a carrier or conjugate that promotes adhesion or adhesion to the device and / or creates a matrix that can be released by diffusion or degradation. In one embodiment, the drug is dissolved in a carrier or conjugate, in which case the drug may be provided in powder or similar form and dissolved in a liquid solvent. The result may be a solution that can be applied to the surface of the shell structure, usually by spraying, painting, dipping, to form a coating or coating. Once the repositioning device is attached to the patient's teeth, compliance indicating the drug may then be released from the coating to the oral environment. Release may be due to activation or deactivation of the carrier or any other triggering mechanism such as by enzymes or proteins in the oral fluid. Alternatively, the release may be due to, for example, degradation of the carrier by contact with oral fluid. In some cases, the conjugate or carrier may evaporate upon application to the surface layer leaving the drug. In these cases, the drug may be released in a manner similar to when the drug described above is attached directly to the surface. It can be appreciated that any drug, particularly fluoride materials, antibiotics, bleach and bad breath refreshers, may also be supplied to the oral environment in this way.

  In another embodiment, the drug is encapsulated or suspended in a layer. Common materials for suspending drugs are semi-solid materials such as gels, jellies or patties. Such materials may be applied to the surface of the shell structure by spraying, painting, or dipping to form a coating or coating. Here, as in all cases, but floating is not limited to a scientific definition and may refer to any situation in which the carrier holds, contains, supports or includes the drug. Alternatively or in addition, the semi-solid material may be precisely mounted in a polymer shell cavity shaped to receive the teeth. The cavity may be filled to any desired level. When the repositioning device is positioned on the tooth, the tooth will directly contact the semi-solid material of the cavity and will push out any excess material as the tooth is inserted into the cavity. Therefore, it is desirable to fill the cavity to a level that avoids excessive overflow of material from the instrument. Drug delivery using semi-solid floating materials is common, for example, in bleaching and fluorine treatments. However, such treatment applies the material through the use of a tray or common appliance that does not apply repositioning forces to the teeth. By modifying the repositioning device, orthodontic treatment may continue throughout the delivery of such medication, as described above. It can be appreciated that any drug, particularly fluoride materials, antibiotics, bleach and bad breath refreshers, may also be supplied to the oral environment in this way.

  Another common material for encapsulating or floating a drug is a controlled release material. Thus, the layer may be composed of a rate limiting material, where the rate controlling (rate limiting) material controls the rate at which the drug is released from the layer. The controlled release material or rate limiting material delivers a predetermined amount of drug at a predetermined rate. Often, such a supply maintains a steady state concentration of the drug in the environment within the desired therapeutic area for an extended period of time. In this way, a prescribed dose is provided. In addition, the ability to sustain the delivery eliminates the need for repeated application of the drug to be delivered in batches to the oral environment.

  As described above, such controlled release materials may be provided as semi-solid materials such as gels, jellies or patties, but these materials are also solids attached to the polymer shell of the repositioning device. It may be provided as a material. One type of controlled release material includes a polymer matrix membrane in which finely dispersed drug particles are suspended. The drug may diffuse through the membrane of the matrix following a concentration gradient. Alternatively or additionally, the drug may be released by degradation of the polymer matrix membrane material. In either case, the controlled release material may be provided as a sheet that can be layered onto the surface of the outer structure. The controlled release sheet may be layered with an elastomeric polymer and vacuum formed over the entire mold to make a repositioning device. The controlled release material may be arranged to be present on the internal or external surface of the device, depending on the material and the desired application. Alternatively, the controlled release sheet may be formed to deliver the drug to the desired site and then layered or bonded to the surface of the polymer shell. Alternatively, the controlled release material may be provided as a tablet or similar amount that can be inserted into the polymeric shell of the repositioning device. The drug may then elute from the tablet into the oral environment over time.

  In another embodiment, the drug may be retained within the pores of the material and may elute out of the pores at a controlled rate. The drug itself may be absorbed into the pores of the material, or the drug may float in a carrier that is absorbed into the pores of the material. In the latter case, the drug may be released from the carrier by diffusion and / or by controlled degradation of the material of the carrier. This may incorporate a rate limiting mechanism in addition to controlled drug release from the pores. As mentioned above, in some cases, the enzyme in the patient's oral fluid will activate the release or degrade the carrier material that releases the drug. It can be appreciated that the drug may be released by any combination of the release methods.

  In a further embodiment, the polymeric shell of the repositioning device itself comprises a controlled release material containing the drug. In this case, at least a portion of the polymeric shell is formed from a controlled release material, where the rate limiting material controls the rate at which the drug is released from the shell. As previously described, the controlled release material may be provided in the form of a single sheet. In this way, the sheet of controlled release material may be vacuum formed to cover the entire patient's dental mold to make the repositioning device itself. In this way, an elastic material may not be required additionally to make the instrument. The controlled release material may be a polymer matrix membrane, a porous material or any suitable material. Controlled release can be designed so that the drug dissolution rate can match the tooth relocation rate. The drug may elute during the repositioning process and is terminated when the teeth reach the desired arrangement defined by the appliance.

  In a further embodiment, the releasing means coupled to at least some of the repositioning devices includes a container formed in the shell of the device in addition to the cavity that receives the teeth. Usually, the rate limiting membrane is placed on the container, where the rate limiting membrane controls the rate at which material is released from the container. The container may be prefilled or preloaded with a drug or substance for delivery. In this case, the instrument may be ready for insertion or use as soon as it is removed from any package without having to load the drug for delivery into the instrument. If the means for discharging is designed for a single delivery period, the instrument may be worn for a defined relocation period and then disposed of. If the means for releasing is designed for multiple delivery periods, the container may be refilled with a drug that is released many times during a defined relocation period. It can be appreciated that any drug, particularly fluoride materials, antibiotics, bleach and bad breath refreshers, may also be supplied to the oral environment in this way.

  In some cases, it may be desirable to change the visual characteristics of the polymer shell of the oral appliance. Such appliances include a polymeric shell having cavities that are configured to be removably mounted over and covering the entire tooth and material on or within the shell that changes the visual characteristics of the shell. Such changes are usually responsive to environmental changes. In some cases, the visual characteristic is a color such as green, red or blue. In this way, the device may appear colored or have a distinctive color within the oral environment or under certain environmental conditions when removed. The described material may also be a dye that changes color in response to changes in temperature. For example, if the instrument is removed from the mouth and the temperature changes from body temperature (37 ° C.) to room temperature (25 ° C.), the color of the dye may change. Similarly, the color of the dye may change when the instrument is drowned with cold water.

  The device can be used to provide an intraoral drug delivery system. In addition to the drugs described above, other compounds can be used as well. For example, a drug-coated instrument can be used to deliver an analgesic to sensitive teeth. The drug substance may simply be a small amount of active ingredient in an analgesic toothpaste or gel, such as Sensodyne®. Painkillers are distributed across the surface of the appliance and are delivered to the patient's sensitive teeth at a substantially constant rate for a relatively long period of time.

  The appliance is preloaded with medication and may be ready for use immediately after removal from any package, but appliances that are not pre-filled or pre-loaded are filled before or just before the appliance is attached to the tooth May be required. Filling may include injecting a drug into the cavity that receives the teeth. As previously described, the cavity may be filled to any desired level. If the appliance is positioned on a tooth, as the tooth is inserted into the cavity, the tooth will contact the drug directly in the cavity. Alternatively, filling may include injecting a drug into a drug release container in the appliance just prior to installing the appliance on the teeth. Thereafter, if the appliance is in place on the teeth, the drug will elute from the container into the oral environment. The elution rate may be controlled by a controlled release membrane that separates the container from the surrounding environment. Filling may also include adhering a rate-limiting material containing the drug to the surface of the appliance prior to attaching the appliance to the teeth. Such materials may include a polymer matrix membrane that is adhered in a removable or non-removable manner to the polymer shell of the device at the desired site for delivery of the drug. And finally, filling may include absorbing the drug into the porous material on or inside the appliance just prior to attaching the appliance to the teeth.

  The means for releasing the drug may include many embodiments including any of the means previously described. Typically, as previously described, the means for releasing the drug comprises a layer containing the drug, and the means for connecting includes adhering the layer to at least a portion of the surface of the device. If the layer consists essentially of the drug, the adhering step may involve covering the surface of the device, spraying, dipping or painting the drug. In this way, the preformed device may simply be covered with the drug prior to insertion into the patient's mouth. If the layer includes an agent in or on the carrier or conjugate, the step of adhering involves attaching the carrier or conjugate to the surface of the device. Similarly, if the drug is encapsulated in a layer, the layer may be attached to the surface of the device. The layer may comprise a single sheet of rate limiting material, where the rate limiting material controls the rate at which drug is released from the layer. In this case, the sheet may be bonded to the surface of the instrument with an adhesive. Alternatively, the sheet may be attached to the surface by press fitting. The sheet and surface may each be processed so that they can be engaged or combined by pressing the sheet and surface together. For example, the sheet may have a molded overhang, and the surface may have a molded inset, where the overhang will match the inset when pressed into the inset and place the sheet in place. Hold. In many instances, the device may be porous and may have a container that can be loaded with the desired drug at any time determined by the treating professional and / or patient to be appropriate. For example, the device can be immersed in a solution of the drug, allowing the device to absorb or adsorb the drug at a particular time.

  Further, the sheet may be pre-shaped into a shape that fits to fit along the surface of the appliance or the surface of the teeth or gums. For example, the sheet may be preformed specifically along the gingival margin to reflect the shape of the surface of one or more teeth or gingiva. If the sheet is connected to the appliance and the appliance is attached to the tooth, the preformed sheet may then be held along its surface. The step of joining may involve any means of attaching the sheet to the instrument. In particular, the pre-formed sheet may further include an adhesive layer that provides sheet bonding to the surface of the device.

1 may be supplemented with additional fillers such as conductive fillers, magnetic fillers, lighting fillers, piezoelectric fillers and / or photosensitive fillers. Material properties, such as modulus, electrical resistance, material permeability and birefringence (material orientation or stress), and lighting, made with or without these fillers For patterns or patterns under special light sources, these properties may vary after changes in structure, configuration and / or spatial spacing between fillers, and thus may change after the device has been worn over time. For example, it has been established that the conductivity of a filled composite is measured by the volume concentration of the filler according to penetration theory. Thus, mechanical deformation or thermal expansion of the non-conductive polymer matrix causes an increase in the average spacing between fillers or a decrease in filler volume concentration and thus a decrease in conductivity. Examples of conductive fillers include metals, graphite, conductive polymers, semiconductors and superconductors. These changes in properties can be used as an indicator for compliance and can be identified by instrumentation. Similarly, the separation of conductive fillers also reduces the thermal conductivity, which is also measured by instrumentation. The filler has a magnetic behavior in the presence of an external stimulus such as a diamagnetic material (Cu, Au, Ag, etc.) and a paramagnetic material (eg, Al, Cr, Na, Ti, Zr, etc.). Or if it exhibits intrinsic magnetic properties such as ferromagnets (Fe, Co, Ni, etc.), antiferromagnets (eg MnO), and ferromagnets (MFe ₂ O ₄ ), the result is a polymer matrix Separation of filler spacing due to mechanical deformation of can also cause a decrease in magnetic properties above the Curie temperature. Mechanical deformation of composites with illumination fillers that exhibit luminescence, fluorescence or phosphorescence will result in a decrease in illumination. The bending deformation or displacement of the piezoelectric fiber can provide a potential that can be used to measure or activate other motorized indicators (eg, low power light emitting diode (LED) light sources). For example, fillers having optical properties determined by ultraviolet (UV), infrared (IR), or an external electric field that changes the absorption coefficient of the visible spectrum can also serve as an indicator of matrix deformation.

  Referring now to FIG. 2A, an embodiment of a display attachment device 200 is shown. The display attachment device 200 includes a polymer well 201, and the well 201 includes a semipermeable membrane 202. The membrane 202 allows bidirectional flow between the well 201 and the interface of the oral environment. Within the well 201, a material 204, such as a staining material, is provided.

  In one embodiment, the dye material 204 is a releasable material, such as a dyed poly (vinyl siloxane) (PVS) material. The PVS material is used to retain the dye and the membrane 202 may be a cellulose acetate membrane. Those skilled in the art will appreciate that other releasable materials such as polyethers, polyurethanes, ethyl vinyl acetate and the like can be successfully utilized to provide the teachings of this patent.

  In another embodiment, well material 204 may be a reactant that reacts with an enzyme or an enzyme from oral fluid. If oral fluid or enzyme from oral fluid enters the well, material 204 reacts with the enzyme and becomes an indicator. Alternatively, a pH indicator can be used as material 204. In yet another embodiment, the membrane 202 may be silicon instead of PVS.

  In another embodiment, the polymer may be a water-soluble polymer comprising a polymer amount with a water-soluble polymer, a lightly cross-linked hydrogel, a hydrogen-bonded plastic that exhibits some slight water resistance. Naturally based water soluble polymers include starch, oxidized starch, cellulose, alkoxylated cellulose, carboxyalkylated cellulose, chitin, chitosan, pectin, hyaluronic acid, protein, and lignin. Water-soluble polymers can also be made from synthetic raw materials via addition / vinyl polymerization, condensation and ring opening. Examples of these types of polymers are poly (vinyl alcohol), polyester and poly (alkylene oxide). The hydrolytic instability of biodegradable polymers is advantageous because the presence of oral fluid promotes polymer degradation.

  Referring now to FIG. 2B, a cross-sectional view of a compliance display attachment device (compliance indicator) 200 is shown. As can be seen, the membrane 202 is positioned directly over the polymer well, bath or housing 201 with releasable material, and / or the dye 204 encapsulated therein. As shown in FIG. 2C, after a predetermined period of time, eg, two weeks, a portion of the dyed PVS material 204 has leached, causing a change in the appearance of the display accessory. The dye is released while the PVS remains inside the device. In this case, a color change occurs, or alternatively, the material volume changes, in which case the size decreases.

  In one embodiment, the compliance indicator 200 comprises a well, tub or housing 201 of a transparent, tooth colored or aesthetically pleasing polymer container. A transparent or translucent semipermeable membrane 202 separates the contents in the vessel 201 of the container from the external oral environment. The contents in the vessel 201 of the container are determined by the overall strategy for monitoring compliance. In one embodiment, the contents diffuse out of the vessel tub 201 through the membrane 202 and into the outside environment. For example, the contents may be a Food and Drug Administration (FDA) approved visible dye that diffuses from the tank 201 through the membrane 202 and into the external oral environment. When the contents are emptied, the color of the contents decreases in brightness and brightness. Colorants permitted by the US FDA for direct addition to human food include Annatto extract, beta carotene, beet powder, canthaxanthin, caramel color, carrot oil, cochineal extract (carmine), cottonseed powder, fruit juice, paprika , Riboflavin, saffron, turmeric, vegetable juice, Food and Drug Cosmetics Act (FD & C) Blue No. 1 (Brilliant Blue) and Blue No. 2 (Indigotin), FD & C Green No. 3 (First Green FCF), FD & C Red No. 3 (Erythrosin) Includes Red No. 40 (Arla Red), FD & C Yellow No. 5 (Tartrazine) and Yellow No. 6 (Sunset Yellow). The website of the FDA Food Safety and Applied Nutrition Center, http: // www. cfsan. fda. gov / ˜dms / col-toc. Other food colorants such as those found in html can be used as well.

  In another embodiment, objects from the outside environment diffuse into the interior and react with the contents 204 in the vessel 201 of the container. For example, glucose molecules from the external environment diffuse through the membrane 202 and react with enzymes in the contents, and the resulting enzyme product interacts with other reactants in the contents to produce color. Bring about changes. As more glucose molecules diffuse into the interior, the color of the contents improves brightness and brightness. A convenient enzyme system is glucose oxidase and horseradish peroxidase. The first enzyme, glucose oxidase, catalyzes the oxidation of glucose to form gluconic acid and hydrogen peroxide. Hydrogen peroxide then reacts with 3-3,5,5'-tetramethylbenzidine (TMB) under the catalysis of horseradish peroxidase, turning yellow TMB to green. Other colorants such as potassium iodide (from green to brown) may also be used. These enzymes can be immobilized inside the tank. The reaction rate, and thus the color change, can be controlled by selecting the permeability of the membrane 202, the concentration of reactants inside the vessel 201, and the method of delivery. The reaction rate or concentration of glucose molecules can also be detected by spectroscopy or other analytical tests. Test results will be associated with treatment compliance.

  With reference now to FIGS. 3A and 3B, another embodiment of a display accessory is shown. In the embodiment of FIG. 3A, a porous polymeric material is provided on the sheet 300. The polymeric material is disposed on the sheet 300 as one or more containers 304. Container 304 may be a well as disclosed above in the description of FIGS. After a predetermined period of use, the polymer material changes appearance, eg, changes in either color or size as shown in FIGS. Other embodiments can include polymers (both thermoplastic and thermoset materials) and composites that utilize the same compliance mechanism as the porous polymeric material.

  Thus, the compliance indicator of FIGS. 3A-3B can be a dye that is encapsulated in a polymer that is released in the presence of oral fluid. The dye may be a colorant that reacts with oral fluid and is released from the polymer. The polymer may be porous, such as a monolithic porous polymer (currently used in chromatography), PVS, high internal phase emulsion (HIPE polymer currently used for drug release), or any macroporous polymer May be a functional polymer. The dyed polymer will be formed in a small button that can be joined to the exterior of the aligner. The amount of dye lost will be consistent with the period during which the aligner has been used. The size of the polymer pores and the size of the dye particles affect the diffusion rate of the dye from the button into the oral fluid environment, and these factors can be controlled by compliance requirements.

  Porous polymers are made by adding “porogen” during the resin polymerization process. The porogen is soluble in the monomer but insoluble in the shaped polymer. As polymerization occurs, pores are formed in the space where the porogen is seen. The latest types of porous polymers are known as “high internal phase emulsions” (“HIPE”). The HIPE structure has a much larger pore diameter than previous porous materials having only angstrom pore diameters.

  Another porous polymer is a monolithic porous polymer currently used in chromatography. The polymerization of this rigid macroporous polymer takes the form of a monomer and porogen, usually a column. In general, the pore volume is approximately equal to the amount of porogen added to the monolith.

  Referring now to FIGS. 4A and 4B, an embodiment of a button of the display accessory 400 is shown. In this embodiment, the biodegradable polymer material is applied to either the tooth or the dental appliance. After a period of use, the polymer material changes either in shape, size or color, and the volume of the biodegradable polymer material is subsequently reduced, as shown in FIG. 4B. In one embodiment, the button is a biodegradable polymer button. The button can be molded from a biodegradable polymer and bonded to the outside of the aligner. The button will have a predetermined degradation period, such as a 2 week degradation period, with oral fluid at all times. In some cases, the polymer can be colored to provide a more visible indication of button disassembly. The size and material will determine the degradation period of the button. However, other factors such as aligner brushing or cleaning would have to be taken into account to determine the optimal button disassembly time.

  Degradation products often define the biocompatibility of the polymer. Synthetic biodegradable polymers are preferred over natural ones due to raw material reliability. The following is a list of common biodegradable polymers: polyglycolide (PGA), polylactide (PLA), l-lactide (LPLA), poly (dl-lactide) (DLPLA), poly (ε-caprolactone) (PCL). ), Polydioxetane (PDO), poly (glycolide-co-trimethylene carbonate) (PGA-TMC), and polyorthoesters.

  FIG. 5 shows still another embodiment of the display attachment device. In this embodiment, the instrument 416 receives an adhesive dye matrix 412. The matrix 412 is sealed at either one end or both ends using the back coat 410. The substance in the matrix 412 can be released to the side between the instrument 416 and the coating 410 or between the two backing coatings. An opening 418 may be provided on one side of the device 416 and the back coat to facilitate dye release. In one embodiment, the transdermal patch may be applied in a manner similar to a transdermal patch that releases a drug. Instead of embedding and releasing the drug in the sticky matrix, the dye is released and the mechanism of dye loss is moisture (oral fluid). In one embodiment, appliance wear compliance is indicated by the color of the adhesive layer, the more dye is lost, the longer the wear time.

  FIG. 6 shows yet another embodiment in which wear indication is achieved through a water soluble coating. In this embodiment, the opaque water-soluble coating 420 is positioned to cover one or more colored areas, sites, spots or spots 422 on the appliance or tooth. The points 422 can be a series of points colored with various thicknesses of the coating 420, each of the presented colors corresponding to a different instrument wear time. In embodiments where the points 422 are engraved into the device, the coating 420 is overlaid on the surface of the device. The dye release mechanism is moisture (oral fluid).

  FIG. 7 shows another embodiment in which the tooth attachment 444A is made from a composite that releases a dye. The dye releasing composition 444A bonded to the teeth is covered by the appliance 416. Over time, the dye releasing composition 444A has less or no color loss compared to the dye loss of the uncovered tooth attachment 444B. The color of the attachment corresponds to the wear time of the aligner. The dye release mechanism is moisture (oral fluid) in this embodiment.

  In still other implementations, a diagnostic indicator can be provided. The diagnostic indicator is similar to the device construction for the compliance indicator and utilizes an inward diffusion strategy that allows biochemical analytes from the external environment to diffuse through the membrane to react to the contents in the vessel tank. In this way, biomarkers from the external environment diffuse through the membrane and directly or indirectly cause color or chemical changes that can be measured by the human eye, laboratory tests, or computerized vision systems. Reacts with reagents inside the contents to induce. As more biomarkers diffuse into the diagnostic indicator, the color of the contents changes, eg, brightness and brightness are improved. Potential biomarkers include microorganisms that can be present in the amount of enzyme, pH, glucose, salt, oral membrane, plaque, oral cavity and oral fluid.

  In one embodiment shown in FIG. 8, the compliance indicator may be a time and temperature indicator 480. Indicator 480 is attached to the oral cavity (either directly on the tooth or on appliance 470) and displays the time when the pre-selected oral temperature environment is reached.

  In yet another embodiment shown in FIG. 9, a plurality of brushes 502 having colored fibers 504 are positioned on the instrument 500. As the brush 502 is gradually eroded by wearing the instrument 500, dyes or other suitable signs of wear in the fiber 504 are presented for visual detection by humans or machines. Alternatively, the brush 502 may be attached to one or more teeth instead of on the appliance 500.

  In yet another embodiment, the compliance indication is made human readable by changing physical, mechanical, and visual properties that are easily observable by the human. In other embodiments, the compliance indication is machine readable. For example, in one embodiment that changes the electrical properties of the instrument while wearing the instrument, electrical measurements can be made by a computer for compliance detection. In another embodiment using a biomarker, a computer with a biomarker sensor can be used in conjunction with a computer program suitable for detecting compliance. In yet another embodiment, the color change can be detected by a computer vision program that senses compliance.

  A computer when a machine-readable storage medium or a device readable by a general or special purpose programmable computer (eg, a program memory or magnetic disk) is read by the computer to perform the procedures described herein. Each program is stored explicitly in the storage medium or device to configure or control the operation of the computer. The inventive system may also be considered integrated into a computer readable storage medium comprised of computer programs, by which the computer is described herein. It can be actuated in a specific or predetermined way to perform the described function.

  Some portions of the present system and corresponding detailed description are presented in terms of algorithms or symbols of operations on data bits in software or computer memory. These descriptions and descriptions are intended to enable those skilled in the art to effectively communicate the essence of their work to others skilled in the art. As used herein, and as a commonly used term, an algorithm is considered a sequence that is self-consistent of steps leading to the desired result. A step is a step that requires physical manipulation of physical quantities. Usually, though not necessarily, these quantities take the form of optical, electrical, or magnetic signals capable of being stored, transferred, combined, compared, and manipulated. It has proven convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or equivalents.

  However, it should be borne in mind that all of these and similar terms are to be associated with the appropriate physical quantities and are merely convenient labels applied to these quantities. Except where specifically stated otherwise, or as is apparent from the description, “processing step” or “calculating step” or “calculating step” or “determining step” or “displaying step” Are similarly represented as physical quantities in a computer system's registers and memory, as physical quantities in a computer system's memory, registers, or other such information storage, transmission or display devices. Refers to the operation and processing of a computer system or similar electronic computing device that manipulates or converts to other data.

  The terms and expressions used in the foregoing specification are used herein for purposes of explanation and not limitation, and the characteristics illustrated or described, or portions thereof, in using such terms and expressions may be used. It is recognized that the equivalents are not intended to be excluded, and therefore the scope of the present invention is defined and limited only by the claims that follow. For example, although a coating or instrument is disclosed as a compliance measurement mechanism, droplets can be used as well to deliver a compliance substance to the patient. Other embodiments for compliance indications can be used as well. While particular embodiments of the present invention have been described herein for purposes of illustration, those skilled in the art will recognize many variations of this detail as defined in the appended claims. It will be apparent that it may be made without departing from the invention.

Claims (1)

Invention described in the specification.

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